Medtronic Market-Released DF4 Lead Imaging

NCT ID: NCT01626768

Last Updated: 2013-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.

The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.

Detailed Description

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Conditions

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Tachycardia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients greater than 18 years of age.
* Patients able and willing to attend imaging session.
* Patients able and willing to give informed consent.
* Patients with an implanted device/lead(s) for a minimum of 3 months.

Exclusion Criteria

* Subjects who require a legally authorized representative to obtain consent.
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Riyadh, , Saudi Arabia

Site Status

London, , United Kingdom

Site Status

Countries

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Saudi Arabia United Kingdom

Other Identifiers

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DF4-Imaging-2012

Identifier Type: -

Identifier Source: org_study_id

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